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ONEJECT Hypodermic Syringe with Reuse Prevention Feature 5 ml 21G x 1 ½"

by PT Oneject Indonesia EUDAMED

Withdrawn Not intended for the EU market

Ref 05685Model Sterile Hypodermic Syringe with Reuse Prevention Feature

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8990067RUPOJIGX Basic UDI-DIDate13 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ONEJECT Hypodermic Syringe with Reuse Prevention Feature
Model / Reference
Sterile Hypodermic Syringe with Reuse Prevention Feature, 05685
Primary DI / UDI-DI
08990067056855

Manufacturer details

EUDAMED SRN
ID-MF-000004875
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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